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FDA Inspection
•Biomat USA, Inc•August 27, 2014

Biomat USA, Inc – FDA Inspection, Aug 27, 2014

Record Details

This FDA Inspection record concerns Biomat USA, Inc, with an inspection on August 27, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Biomat USA, Inc
Inspection Date
August 27, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 68d6fb44-8a42-48d7-a20c-56bc2aa884de

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
894511
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  2. 21 CFR 640.64(e)Prevention of contamination

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Biomat USA, Inc

3
DateClassificationOfficeProject area
December 13, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 14, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 21, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Biomat USA, Inc
  • FDA Inspection 1225670 - 2023-12-13
  • FDA Inspection 1019092 - 2017-07-14
  • FDA Inspection 731445 - 2011-06-21

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